Clinical Trial: C-reactive Protein (CRP)-Guided Management Algorithm for Adults With Acute Cough

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Controlled Trial of a C-reactive Protein (CRP)-Guided Management Algorithm for Adults With Acute Cough Illness in the Emergency Department

Brief Summary:

We aim to evaluate the impact of a CRP-guided management algorithm for adults with acute cough illness. More specifically, we will examine both process of care and clinical outcomes:

  1. Processes of care (i.e., chest x-rays ordered, antibiotic treatment, length-of-time in the ED). We hypothesize that CRP-guided management will be associated with a decrease in the antibiotic prescription for acute cough illness from 50 percent to 30 percent.
  2. Clinical outcomes (i.e., duration of illness, any return visit, return visit with a diagnosis of pneumonia, hospitalization, subsequent antibiotic use, satisfaction with care). We hypothesize that there will be no difference in the proportion of patients feeling back to normal within 2 weeks of their ED visit for acute cough illness (about 60 percent, 95% confidence interval=50 to 70 percent).

Detailed Summary:

We have developed a CRP-guided management algorithm based on recent studies in which the accuracy of CRP for identifying patients with pneumonia was confirmed.(10;11) Importantly, these 2 studies each confirmed that CRP levels provide additional diagnostic support beyond that gained from application of clinical prediction rules. In the proposed study, we will recommend that physicians first assess the probability of pneumonia based on clinical findings, in accordance with current practice recommendations as follows: 1) Low Clinical Suspicion (<5% probability of pneumonia): Absence of fever (T>38C), tachycardia (HR>100), or tachypnea (RR>24), and normal chest examination. These patients should receive symptomatic therapy, and do not require CXR or antibiotic treatment; 2) High Clinical Suspicion (>30% probability of pneumonia): At least 1 abnormal vital sign and abnormal chest examination. These patients receive CXR and antibiotics based on CXR findings or high clinical suspicion; 3) Intermediate Clinical Suspicion (5-30%): All others. Current practice guidelines recommend considering CXR in these patients, however no further guidance is provided for the management of these patients.

After assessing the clinical probability of pneumonia, CRP levels will be provided for a random subset of patients. A CRP level <10 mg/L corresponds with a very low probability of bacterial pneumonia. Thus, for patients with low and intermediate-probability of pneumonia based on clinical grounds, a CRP <10 mg/L should confirm that no CXR or antibiotics are necessary in routine cases (See attached algorithm). A CRP level > 100 mg/L corresponds with a substantially elevated probability of pneumonia. Thus, for patients with low and intermediate-probability of pneumonia based on clinical grounds, a CRP >100 mg/L would support CXR ordering, and for patients with high clin
Sponsor: University of California, San Francisco

Current Primary Outcome: Chest X-ray utilization, Antibiotic treatment, Time in emergency department, Subsequent office or emergency department visits (within 2 weeks; Subsequent hospitalization, Time-to-illness resolution

Original Primary Outcome:

  • 1. Chest X-ray utilization (chart review)
  • 2. Antibiotic treatment (chart review)
  • 3. Time in emergency department (chart review)
  • 4. Subsequent office or emergency department visits (within 2 weeks) (telephone follow-up)
  • 5. Subsequent hospitalization
  • 6. Time-to-illness resolution (telephone follow-up)
  • 7. Satisfaction with care


Current Secondary Outcome: Satisfaction with care

Original Secondary Outcome:

Information By: University of California, San Francisco

Dates:
Date Received: September 19, 2005
Date Started: October 2005
Date Completion:
Last Updated: May 20, 2011
Last Verified: May 2011